Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Obecabtagene autoleucel (Aucatzyl) may be considered medically necessary when the following criteria are met:
Acute Lymphoblastic Leukemia
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Individual 18 years of age or older;
and
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Individual has relapsed or refractory confirmed B cell acute lymphoblastic leukemia ( R/R B-ALL) and has tried greater than or equal to two (2) prior lines of therapy;
or
-
Individual has R/R Philadelphia chromosome-positive B-ALL following therapy that has included Tyrosine kinase inhibitors (TKIs) or if TKI is contraindicated;
and
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Documentation of CD19 tumor expression in bone marrow or peripheral blood CD19 tumor expression;
and
- When ALL of the following criteria are met:
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Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 or 1;
and
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No prior CD19 targeted therapy other than blinatumomab or has experienced Grade 3 or higher neurotoxicity following blinatumomab;
and
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No history of CNS disease or malignancies;
and
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Individual must not have active graft-vs-host disease;
and
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No prior gene therapy;
and
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Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) less than five (5) times the upper limit of normal;
and
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No presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management;
and
-
Left ventricular ejection fraction greater than or equal to 40%;
and
- No live vaccination within six (6) weeks prior to initiation of lymphodepleting chemotherapy
The use of obecabtagene autoleucel (Aucatzyl) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Dosage and schedule for obecabtagene autoleucel (Aucatzyl) are dependent on individual tumor burden requiring two (2) split dose infusions to reach the target dose of CAR-T cells.
Note:
A REMS program is not required for obecabtagene autoleucel (Aucatzyl). Refer to product label and treatment center guidelines for supportive care measures.
Note:
The second split dose is not recommended in the event an individual experiences a severe adverse event (AE) requiring discontinuation of treatment after the first split dose (i.e. Grade 2 or higher immune effector cell-associated neurotoxicity syndrome (ICANS) or Grade 3 or higher events which include cytokine release syndrome (CRS), pulmonary toxicities, or other clinically relevant adverse reactions).
Additional infusions of obecabtagene autoleucel (Aucatzyl) or infusion of alternative CAR-T products after the two (2) split dosage regimen are considered experimental/investigational and therefore, non-covered.
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